Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125469981 | 12546998 | 1 | I | 201604 | 20160705 | 20160711 | 20160711 | EXP | FR-AFSSAPS-RE20160637 | FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-44036FF | BOEHRINGER INGELHEIM | 68.54 | YR | F | Y | 0.00000 | 20160711 | OT | FR | FR |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125469981 | 12546998 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | Y | 22512 | 150 | MG | CAPSULE | BID | |||||
| 125469981 | 12546998 | 2 | SS | LASILIX | FUROSEMIDE | 1 | Oral | 40 MG | Y | 0 | 40 | MG | TABLET | QD | |||||
| 125469981 | 12546998 | 3 | SS | PERINDOPRIL | PERINDOPRIL | 1 | Oral | Y | 0 | QD | |||||||||
| 125469981 | 12546998 | 4 | SS | GABAPENTINE | GABAPENTIN | 1 | Oral | 2400 MG | Y | 0 | 800 | MG | TID | ||||||
| 125469981 | 12546998 | 5 | C | FLECAINE LP | FLECAINIDE | 1 | Oral | 300 MG | 0 | 150 | MG | CAPSULE | BID | ||||||
| 125469981 | 12546998 | 6 | C | ATORVASTATINE | ATORVASTATIN | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 125469981 | 12546998 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 20 MG | 0 | 10 | MG | BID | |||||||
| 125469981 | 12546998 | 8 | C | NEBIVOLOL. | NEBIVOLOL | 1 | Oral | 5 MG | 0 | 5 | MG | TABLET | QD | ||||||
| 125469981 | 12546998 | 9 | C | VESICARE | SOLIFENACIN SUCCINATE | 1 | Oral | 5 MG | 0 | 5 | MG | COATED TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125469981 | 12546998 | 1 | Product used for unknown indication |
| 125469981 | 12546998 | 2 | Hypertension |
| 125469981 | 12546998 | 3 | Hypertension |
| 125469981 | 12546998 | 4 | Back pain |
| 125469981 | 12546998 | 5 | Atrial fibrillation |
| 125469981 | 12546998 | 6 | Dyslipidaemia |
| 125469981 | 12546998 | 7 | Product used for unknown indication |
| 125469981 | 12546998 | 8 | Hypertension |
| 125469981 | 12546998 | 9 | Urinary incontinence |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125469981 | 12546998 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125469981 | 12546998 | Acute kidney injury | |
| 125469981 | 12546998 | Coagulopathy | |
| 125469981 | 12546998 | Dizziness | |
| 125469981 | 12546998 | Malaise | |
| 125469981 | 12546998 | Muscular weakness | |
| 125469981 | 12546998 | Overdose |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125469981 | 12546998 | 1 | 201605 | 0 | ||
| 125469981 | 12546998 | 2 | 201605 | 0 | ||
| 125469981 | 12546998 | 3 | 201605 | 0 | ||
| 125469981 | 12546998 | 4 | 201605 | 0 |